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Guide to Statistics and Methods
Reporting Guidelines
April 7, 2021

The CONSORT Framework

Author Affiliations
  • 1Feinberg School of Medicine, Department of Surgery, Surgical Outcomes and Quality Improvement Center, Northwestern University, Chicago, Illinois
  • 2Department of Emergency Medicine, Harbor University of California, Los Angeles Medical Center, Torrance,
  • 3David Geffen School of Medicine at University of California, Los Angeles
  • 4Statistical Editor, JAMA Surgery
  • 5Department of Surgery, VA Boston Healthcare System, Boston, Massachusetts
  • 6Department of Surgery, Boston University School of Medicine, Boston, Massachusetts
  • 7Harvard Medical School, Boston, Massachusetts
JAMA Surg. 2021;156(9):877-878. doi:10.1001/jamasurg.2021.0549

The Institute of Medicine defines the quality of health care as the “degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”1 Yet only a minority of surgical management decisions have historically been based on randomized clinical trials (RCTs). Fortunately, surgeons are now regularly conducting RCTs, and the results are increasingly being translated and implemented into clinical practice.2 In the past, reporting of RCTs was widely variable and often resulted in an inability to interpret and apply study findings to actual clinical practice.3 To address inadequate reporting of RCTs, the Consolidated Standards of Reporting Trials (CONSORT) Group first outlined a set of reporting principles in 1996. These original guidelines were updated twice, in 2001 and in 2010.4 Strict adherence to CONSORT has been widely endorsed by the medical community, including all major medical journals and editorial boards including all JAMA Network journals. In this overview, we describe CONSORT, emphasize several important considerations when using it, and point out its limitations.

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